Full Press Release Details
Investor Presentation
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Forward-looking Statements
This presentation contains forward-looking statements, within the meaning of the federal securities laws, related to future
events and future financial performance which include statements about our expectations, beliefs, plans, objectives,
intentions, goals, strategies, assumptions and other statements that are not historical facts. Forward-looking statements
are subject to known and unknown risks and uncertainties and are based on potentially inaccurate assumptions, which
could cause actual results to differ materially from expected results, performance or achievements expressed or implied
by statements made herein. Our actual results could differ materially from those anticipated in forward-looking statements
for many reasons, including, but not limited to, uncertainties relating to: the timing and results of future clinical trials
including without limitation the OM, HCC, ICC, and mCRC trials in the Company's Clinical Development Program, clinical
adoption, use and resulting sales, if any, for the CHEMOSAT system in Europe, our ability to obtain reimbursement for
the CHEMOSAT system in various markets including without limitation Germany and the United Kingdom, our ability to
successfully commercialize the Melphalan/HDS system and the potential of the Melphalan/HDS system as a treatment for
patients with primary and metastatic disease in the liver, the Company's ability to satisfy the requirements of the FDA's
Complete Response Letter relating to the ocular melanoma indication and the timing of the same, approval of the
Melphalan/HDS system by the U.S. FDA, acceptance of the Phase 3 trial publication, the impact of the presentations at
ESSO and SSO and future clinical results consistent with the data presented, approval of the current or future
Melphalan/HDS system for delivery and filtration of melphalan or other chemotherapeutic agents for various indications in
the U.S. and/or in foreign markets, actions by the FDA or other foreign regulatory agencies, our ability to successfully
enter into strategic partnership and distribution arrangements in foreign markets and the timing and revenue, if any, of the
same, uncertainties relating to the timing and results of research and development projects, and uncertainties regarding
our ability to obtain financial and other resources for any clinical trials, research, development, and commercialization
activities. These factors, and others, are discussed from time to time in our filings with the Securities and Exchange
Commission including the section entitled Risk Factors'' in our most recent Annual Report on Form 10-K and our Reports
on Form 10-Q and Form 8-K.
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About Delcath Systems
A specialty pharmaceutical and medical device oncology company with a
principal therapeutic focus on the treatment of primary liver cancer and other
cancers that have metastasized to the liver
Proprietary system isolates the liver from circulation, delivers a substantially
higher concentration of chemotherapy (melphalan) compared with systemic
doses, and filters most of the chemotherapy out of the blood prior to returning
it to the patient to reduce myleosuppressive side effects
In late-stage clinical development in the U.S. with initial commercial activities
Initially pursuing orphan indications in metastatic ocular melanoma,
hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma
Seeking to Make a Clinically Meaningful Difference For Cancer Patients With Liver Dominant Disease
DELCATH SYSTEMS, INC
Investment Highlights
Believe We are Positioned to Capitalize on Large, Compelling Market Opportunity
Late-stage asset - demonstrated clinically meaningful efficacy in more than
600 procedures and multiple tumor types
Active clinical program - initiating global Phase 3 study in ocular
melanoma; HCC/ICC Phase 2 program ongoing
Unique, highly differentiated solution - orphan designations create
Large market opportunity - cancers of the liver remain a multibillion-dollar
unmet medical need; early commercial activity EU
Imminent valuation milestones - 2015 value drivers include publications,
reimbursement and clinical data
Attractive business model - initial orphan focus and anticipated high gross
margins form basis of profitable long-term model
Experienced management team - aligned with requirements of clinically
driven pharmaceutical industry
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2014-2015 Milestones
2014 Accomplishments
Phase 2 HCC trial open and first patient treated
100th patient treated in Europe (commercial and clinical)
Positive efficacy data from three institutions presented at ESSO 2014
Product revenue increased 118% Y/Y to $1.1 million
Cash burn reduced by 50% Y/Y
NUB reimbursement decision in Germany - Value 4 awarded for 2015
Submit Phase 3 metastatic melanoma trial results for publication
o EU registry open for enrollment
o ICC cohort open for enrollment
o Initiation of Phase 3 metastatic ocular melanoma program
o Interim evaluation on HCC/ICC program
Executing on Multiple Fronts to Create Value
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The Liver: A Life-Limiting Organ
Cancers of the liver remain a major unmet medical need
o Large global patient population - approximately 1.2 million* patients
diagnosed annually with primary or metastatic liver cancer
o The liver is often the life-limiting organ for cancer patients and one of the
leading causes of cancer death
o Prognosis after liver involvement is poor, with overall survival generally
CHEMOSAT Melphalan/HDS is a proprietary product
uniquely positioned to potentially treat the entire liver as a
standalone or complementary therapy
* SOURCE - 2008 GLOBOCAN
Effective Liver Cancer Treatment Remains a Major Unmet Medical Need
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Existing Liver Cancer Treatments Landscape
Existing Liver Cancer Treatments Have Limitations
| Treatment | Advantages | Disadvantages |
| Systemic | - Non-invasive - Repeatable | - Systemic toxicities - Limited efficacy in liver |
| Regional (e.g., Isolated Hepatic Perfusion) | - Therapeutic effect - Targeted | - Invasive/limited repeatability - Multiple treatments are required but not possible |
| Focal (e.g., surgery, radioembolization, chemoembolization, radiofrequency ablation) | - Partial removal or treatment of tumors | - Only 10%-20% are resectable - Invasive and/or limited repeatability - Treatment is limited by tumor size, number of lesions and location - Tumor revascularization - Cannot treat diffuse disease |
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Concentrating the Power of Chemotherapy for Disease Control in the Liver
Our Solution: Whole Organ-Focus Disease Control
Our proprietary system isolates the liver circulation, delivers a
high concentration of chemotherapy (melphalan) and filters
most of the chemotherapy out of the blood prior to returning it
The procedure typically takes approximately 2-3 hours to
complete and involves a team including the interventional
radiologist and perfusionist
We believe more than 180 treatments with improved device
and procedure in the U.S. and EU provide confidence safety
can be validated in a controlled setting
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